CA2520197A1 - Sachet for a pharmaceutical composition - Google Patents

Sachet for a pharmaceutical composition Download PDF

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Publication number
CA2520197A1
CA2520197A1 CA002520197A CA2520197A CA2520197A1 CA 2520197 A1 CA2520197 A1 CA 2520197A1 CA 002520197 A CA002520197 A CA 002520197A CA 2520197 A CA2520197 A CA 2520197A CA 2520197 A1 CA2520197 A1 CA 2520197A1
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CA
Canada
Prior art keywords
sachet
sachet according
per unit
unit area
weight per
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002520197A
Other languages
French (fr)
Inventor
Carin Widerstrom
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ferring BV
Original Assignee
Ferring B.V.
Carin Widerstrom
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36655488&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2520197(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from EP20030388023 external-priority patent/EP1470819A1/en
Application filed by Ferring B.V., Carin Widerstrom filed Critical Ferring B.V.
Publication of CA2520197A1 publication Critical patent/CA2520197A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B15/12—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of paper or cardboard
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/606—Salicylic acid; Derivatives thereof having amino groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B32B15/085—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/20—Layered products comprising a layer of metal comprising aluminium or copper
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/10—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of paper or cardboard
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/20—Properties of the layers or laminate having particular electrical or magnetic properties, e.g. piezoelectric
    • B32B2307/21—Anti-static
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/72—Density
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B32B2307/7242—Non-permeable
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B32B2307/7242—Non-permeable
    • B32B2307/7246—Water vapor barrier
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/726—Permeability to liquids, absorption
    • B32B2307/7265—Non-permeable
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00—Polyalkenes
    • B32B2323/04—Polyethylene
    • B32B2323/046—LDPE, i.e. low density polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/40—Closed containers
    • B32B2439/46—Bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1303—Paper containing [e.g., paperboard, cardboard, fiberboard, etc.]

Abstract

The present invention is directed to a sachet for a pharmaceutical composition, comprising the layers: paper; bonding layer; barrier layer; and sealing layer.

Description

SACHET FOR A PHARMACEUTICAL COMPOSITION
Field of the Invention The present invention concerns a sachet for a pharmaceutical composition.
The present writ claims priority from the Danish patent application PA 2003 00612, The European patent application EP 03388023, and the US provisional patent application 60/464649.
Technical Background Oral pharmaceutical formulations comprising mesalazine are known, which are either tablets or granulate.
Granulate may be packed in sachets. For the purposes of the present invention a "sachet" will refer to an envelope or bag for a granulate, while "granulate" refers to particles, granulate or spheronised particles.
Known sachets tend to suffer from the draw back of complicated manufacturing methods or high production costs. In order to being accepted by consumers, a sachet should preferably be easy to open without the use of scissors. Upon pouring granulate from a sachet preferably as little material as possible should be lost. Static electricity may build up between certain granulate types and sachets. This is dependent of the type of granulate as well as the type of sachet. If static electricity is present, it tends to be difficult to pour granulate from the sachet. Finally, granulate in a sachet may be sensitive to degradation by light, humidity and/or air.
This is also dependent of the type of sachet as well as the type of granulate.
Disclosure of the Invention These problems and others mentioned below are addressed by aspects of the invention.
CONFIRMATION COPY
For the purposes of the present invention the term "mesalazine" also encompasses pharmaceutically acceptable salts and esters thereof, such as those mentioned in WO
97/23199 p. 15, 1. 17 - p. 6, 1. 12, as well as prodrugs, such as balsalazide.
The formulation, to be stored in a sachet according to the invention, is preferably in the form of a particulate material, e.g. granulate, spheres, pellets, particles, preferably granulate.
The present sachet may be used for any pharmaceutical formulation, but is especially suitable for storing pharmaceuticals comprising sensitive compounds such as mesalazine.
According to an aspect, the present invention concerns a sachet, comprising the layers:
i) paper;
ii) bonding layer, preferably an adhesive such as polyethylene;
iii) barrier layer, preferably aluminium foil; and iv) sealing layer, preferably low density polyethylene.
Mesalazine is sensitive to humidity, atmospheric air and/or light. A sachet for a product containing mesalazine should therefore preferably provide a barrier to humidity, atmospheric air and light. The sachet should also be easy to open for a patient, preferably without the use of additional tools, such as scissors. It has been a problem to provide a sachet with the necessary barrier properties without sacrificing the possibility of tearing open the sachet with human fingers. Further, existing sachets tend to suffer from the build up of static electricity. Preferably, a sachet should be easy to manufacture, easy to fill, easy to empty, and have an appealing look to improve patient compliance.
This aspect provides a sachet giving long storage stability for a pharmaceutical composition contained therein, e.g. where the active pharmaceutical ingredient is mesalazine. Further, the sachet is easy to tear and static electricity is eliminated, providing for a sachet which may be emptied completely for its contents. The combination of the sachet and the oral formulation according to the present invention provides for little build up of static electricity.
The outer paper i) has in a preferred embodiment a weight per unit area of 10-100 g/m2, preferably 30-70 g/m2, more preferred 40-60 g/m2, most preferred 50 g/m2.
Paper having a weight per unit area outside the range of 10-100 g/mz are hardly suitable in industrial manufacturing of sachets. Paper having a weight per unit area below about 30-40 g/cm2 tend to break in manufacturing equipement for sachets. For paper having a weight per unit area above about 60-70 g/cm2 it is difficult to shape the material to sachets. Optimal results have been achieved with a weight per unit area above of about 50 g/cm2.
According to an aspect, the bonding layer ii) preferably has a weight per unit area of 6-20 g/mz, preferably 9-18 g/m2, more preferred 12-15 g/m2. If a very thin layer is used, it usually neccesitate the use of expensive special polymers to achieve an appropriate coverage. If a thick layer is applied, it inherently more expensive and hard to avoid an uneven layer.
According to an aspect, the barrier layer iii) preferably has a thickness of 6-30 Vim, more preferred 7-25 ~,m, preferably 9-25 Vim, more preferred 8-20 Vim, preferably 9-15 Vim, more preferred 12 ~,m.
Sachet according to any of the preceding claims, wherein said sealing layer iv) has a thickness of 15-50 Vim. If a very thin layer is applied, it has a tendency not to cover the surface completely. If a very thick layer is applied, it is hard to weld through, and any heating applied may not warm evenly.
According to an aspect, the sealing layer iv) preferably has a weight per unit area of 10-100 g/m2, more preferred 15-75 g/m2, preferably 20-50 g/m2, more preferably 30-40 g/mz, most preferred 35 g/m2.
According to an aspect, the present invention concerns the use of the sachet for a pharmaceutical composition according to the invention.
The sachet has proven suitable for storing the pharmaceutical compositions according to the invention.
According to an aspect, the present invention concerns the use of the sachet for medical purposes.
A sachet according to the present sachet is especially suitable for a pharmaceutical formulation comprising mesalazine or a pharmaceutically acceptable salt thereof.
The present sachet has a remarkably low tendency to build up static electricity. This has formerly especially been a problem with mesalazine granulate. As an example of such a mesalazine product may be mentioned granulate obtainable according to the patent application PCT/DKO1/00677.

According to an aspect of the present invention it is not limited to the use of mesalazine as the active ingredient in granulate in the present sachet, but also relates to other active ingredients, such as the ingredients 5 mentioned in WO 00/44353, p. 12-16.
According to an aspect of the present invention further excipients may be comprised in the composition according to the invention, such as fillers, disintegrants, pH
adjusters, or surfactants. Such excipients are well known from the literature, see e.g. WO 00/44353, p. 16-20, for a number of suitable excipients.
Some excipients are hygroscopic. As an example of such excipient povidone may be mentioned. If an active ingredient is to be formulated with a hygroscopic excipient, the need for a suitable sachet is emphasized.
The present sachet is suitable for being used for pharmaceuticals comprising at least one hygroscopic excipient.
Example The material of a sachet had the following composition:
Paper, claycoated 50 g/m2 Polyethylene, low density 12 g/m2 Aluminium foil 12 ~m Polyethylene, low density 35 g/mz For the present example 12 g/m2 PE corresponds to 13 Vim, and 35 g/mz PE corresponds to 38 Vim. The material had a grammage of 129 g/m2. The permeability to water vapour was <0.05 g/m2, 24 h, 25°C, 75% RH, and to OZ <0.05 ml/m2, 24 h, atm, 23°C, 75% RH.
The sachets were folded around the filling tube of a filling/sealing station, such that the paper was on the outside of the sachet, and then sealed lengthwise, with a low density polyethylene as a sealing layer. After forming the cross seal at the bottom the sachet is filled with granulates, and then sealed again at the top and finally cut.
All citations are incorporated in their entirety by reference.

Claims (16)

1. Sachet for a pharmaceutical composition, comprising the layers:

i) paper;
ii) bonding layer;
iii) barrier layer; and iv) sealing layer.
2. Sachet according to claim 1, wherein said barrier layer is an aluminum foil, said bonding layer is preferably of polyethylene, and said sealing layer is preferably a low density polyethylene.
3. Sachet according to claim 1 or 2, wherein said paper i) has a weight per unit area of 10-100 g/m2.
4. Sachet according to claim 3, wherein said paper i) has a weight per unit area of 30-70 g/m2.
5. Sachet according to claim 4, wherein said paper i) has a weight per unit area of 40-60 g/m2.
6. Sachet according to any of the preceding claims, wherein said bonding layer ii) has a weight per unit area of 6-20 g/m2.
7. Sachet according to claim 6, wherein said bonding layer ii) has a weight per unit area of 9-18 g/m2.
8. Sachet according to claim 7, wherein said bonding layer ii) has a weight per unit area of 12-15 g/m2.
9. Sachet according to any of the preceding claims, wherein said sealing layer iv) has a thickness of 15-50 µm.
10. Sachet according to any of the preceding claims, wherein said sealing layer iv) has a weight per unit area of 10-100 g/m2, more preferred 15-75 g/m2, preferably 20-50 g/m2, more preferably 30-40 g/m2, most preferred 35 g/m2.
11. Sachet according to any of the preceding claims, wherein said barrier layer iii) has a thickness of 6-30 µm, more preferred 7-25 µm, preferably 9-25 µm, more preferred 8-20 µm, preferably 9-15 µm, more preferred 12 µm.
12. Sachet according to any of the preceding claims, containing a pharmaceutical formulation.
13. Sachet according to claim 12, wherein said pharmaceutical formulation comprises mesalazine or a pharmaceutically acceptable salt thereof.
14. Sachet according to claim 12 or 13, said sachet containing an oral pharmaceutical formulation in the form of a granulate comprising more than 55% by weight of mesalazine or a pharmaceutically acceptable salt thereof.
15. Use of sachet according to any of the preceding claims for a pharmaceutical composition.
16. Use of a sachet according to any of the claims 1 - 14 for medical purposes.
CA002520197A 2003-04-23 2004-04-22 Sachet for a pharmaceutical composition Abandoned CA2520197A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US46464903P 2003-04-23 2003-04-23
DKPA200300612 2003-04-23
EP03388023.8 2003-04-23
EP20030388023 EP1470819A1 (en) 2003-04-23 2003-04-23 High drug load mesalazine sachet
DKPA200300612 2003-04-23
US60/464,649 2003-04-23
PCT/EP2004/004280 WO2004093883A2 (en) 2003-04-23 2004-04-22 Sachet for a pharmaceutical composition

Publications (1)

Publication Number Publication Date
CA2520197A1 true CA2520197A1 (en) 2004-11-04

Family

ID=36655488

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002520197A Abandoned CA2520197A1 (en) 2003-04-23 2004-04-22 Sachet for a pharmaceutical composition
CA2520026A Expired - Lifetime CA2520026C (en) 2003-04-23 2004-04-23 High drug load mesalazine sachet

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2520026A Expired - Lifetime CA2520026C (en) 2003-04-23 2004-04-23 High drug load mesalazine sachet

Country Status (20)

Country Link
US (3) US20070042143A1 (en)
EP (3) EP1615619A2 (en)
JP (4) JP2007523664A (en)
KR (1) KR100849966B1 (en)
CN (1) CN1777430B (en)
AU (1) AU2004231316B2 (en)
CA (2) CA2520197A1 (en)
CY (1) CY1115560T1 (en)
DK (1) DK1615648T3 (en)
ES (1) ES2486245T3 (en)
HK (2) HK1083312A1 (en)
IL (1) IL170978A (en)
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